Latest From Laura Helbling
The Biden Administration is hoping that it can attach funding for a national hepatitis C ‘subscription’ program into the delayed fiscal 2024 appropriations bills.
US FDA is emphasizing the need to assess the effects of menopause on drug safety and efficacy as a continuation of the agency’s efforts to encourage clinical trial sponsors to look more systematically for differences in clinical trial subpopulations.
Institute for Clinical and Economic Review continues to assign high values to novel gene therapies, suggesting that Orchard’s pending ‘arsa-cel’ for MLD could be cost effective at a price as high as $4 million per treatment.
After some success in enacting new regulatory and exclusivity incentives in the US over the past decade, antibiotic research advocates are urging action on the payment/reimbursement side. One start-up CEO argues that Medicare needs to rethink its approach to payment for hospital antibiotics.
US FDA will be transitioning from the ‘diversity plans’ outlined in recent guidance to the new, legislatively directed ‘diversity action plans’ by the end of 2023. The oncology group is leading the way in gathering early perspectives on industry approaches.
The US FDA is offering its first formal advice for potential approaches to develop psychedelic drugs for therapeutic indications. But it won’t be easy.